A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity

NCTNCT04969939Other idNN9775-4708Other idU1111-1254-9046

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 120 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 15 Jul 2021
Primary completion: 6 Dec 2022
Completion: 30 Jan 2023
First posted: 21 Jul 2021
Last update posted: 8 Jan 2026
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2021202220232024

Ph 2
A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
NCT04969939
15 Jul 2021 to 30 Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.

Interventions

Semaglutide 2.4 mg and NNC0165-1875 2.0 mgDrug
Semaglutide 2.4 mg and placebo 2.0 mgDrug
Semaglutide 2.4 mg and NNC0165-1875 1.0 mgDrug
Semaglutide 2.4 mg and placebo 1.0 mgDrug

Arms4

Experimental
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
Placebo comparator
Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)
Participants will receive placebo as an add on to semaglutide 2.4 mg.
Experimental
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
Placebo comparator
Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)
Participants will receive placebo as an add on to semaglutide 2.4 mg.

Primary outcomes2

Outcomes the sponsor listed as primary.

Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
Time frame · Part 1: From time of dosing (day 1) to follow-up (week 24)
Registry description
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
Part 2b: Percentage Change in Body Weight
Time frame · Part 2: Randomisation (week 32), end of treatment (week 48)
Registry description
Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

Secondary outcomes(13)

Part 2b: Change in Body Weight (kg)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Change in Glycosylated Haemoglobin (HbA1c)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.
Part 2b: Change in Fasting Plasma Glucose (FPG)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Change in FPG (measured in millimoles per liter \[mmol/l\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Change in Fasting Insulin
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Change in fasting insulin (measured in picomoles per liter \[pmol/l\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Change in Waist Circumference
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Change in waist circumference (measured in centimeter \[cm\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)
Time frame · Part 2b: Randomisation (week 32), end of treatment (week 48)
Registry description
Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)
Time frame · From randomisation (week 32) to end of the trial (week 56)
Registry description
An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)
Time frame · From randomisation (week 32) to end of the trial (week 56)
Registry description
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Part 1: From time of dosing (day 1) to follow-up (week 24)

Part 1: Number of Treatment-emergent Adverse Events (TEAEs)

Group	Value (Events)
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	56
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg	71
Part 1: Placebo + Semaglutide 2.4 mg	37

Primary outcomeMean· Part 2: Randomisation (week 32), end of treatment (week 48)